Diarrhoeal Disease
Conditions
Interventions
Sponsors
Gates Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years and = 50 years. • Able and willing to provide written informed consent. • Reside within Lusaka district and available for scheduled follow-up. • Willing to undergo two endoscopy procedures with serial sample collection.
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding. • Active GI disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding). • Known severe immunodeficiency (HIV with CD4 20 mg/day prednisolone for >2 weeks). • Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities). • Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated. • Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration. • Any condition judged by the investigator to compromise participant safety or data integrity. • Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier. Pregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Feasibility of generating high-quality spatial transcriptomic data from intestinal biopsies 2. Participant completion of scheduled study procedures | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Temporal and spatial gene expression changes in intestinal tissue following vaccination 2. Identification of immune signatures associated with oral rotavirus vaccine response 3. Correlation between tissue-level immune responses and serologic or stool-based biomarkers | — |
Countries
Zambia
Contacts
Public ContactStanley Mwale
QAQC Coordinator
Outcome results
None listed